Udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had a damaged cable was confirmed.Further, it was found that the motor did not run constantly as it was corroded.Also the resistance values of the keypad of the hand control set were out of range and the buttons were not functioning.The motor, motor cable and the hand control set were replaced and the device was repaired, tested and found to be fully functional.Fluid ingress into the system and contact with the motor is responsible for the corrosion of the motor.The corroded motor has a tendency to stick and not turn.User mishandling of the device is one possible root cause of the damage to the motor cable.However, given the information provided, we cannot discern a definitive root cause of the same, along with that of the defective keypad of the hand control set.A manufacturing record evaluation was performed for the finished device (serial number: (b)(4), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
|
It was reported by the affiliate in (b)(6) that during an unknown surgery on an unknown date, it was observed that the hand piece device had a damaged cable.During in-house engineering evaluation, it was determined that the motor did not run constantly as it was corroded.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
|